Patient Enrolled at the Cancer Clinical Trial
Unit, CALHN, Royal Adelaide Hospital
Aethlon's Trial is a Safety, Feasibility, and
Dose Finding Study of the Hemopurifier® in Patients with Solid
Tumors Not Responding to Anti-PD-1 Antibodies
SAN
DIEGO, Nov. 11, 2024 /PRNewswire/ -- Aethlon
Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused
on developing products to treat cancer and life-threatening
infectious diseases, today announced enrollment of the first
patient in its Australian safety, feasibility and dose-finding
clinical trial of the Hemopurifier® in patients with solid tumors
who have stable or progressive disease during anti-PD-1 monotherapy
treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab)
(AEMD-2022-06 Hemopurifier Study). The patient was enrolled on
October 29, 2024, by Prof.
Michael Brown and his staff at the
Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital in
Australia.
The first patient completed screening activities confirming
their eligibility on November 8,
2024, and has now entered a two-month run-in period,
receiving anti-PD-1 therapy. During this time, concentrations of
Extracellular vesicles (EVs) and anti-tumor T cell activity will be
measured. If imaging after this two-month run-in period reveals no
improvement in the patient's tumor, they will be treated with the
Hemopurifier, followed by monitoring to identify decreases in EV
concentrations and improvements in T cell anti-tumor activity.
"Enrollment of the first patient represents the achievement of a
critical milestone for Aethlon Medical in the clinical development
of the Hemopurifier in Oncology," stated Steven LaRosa, MD, Chief Medical Officer of
Aethlon Medical. "We are thrilled with the pre-screening activity
being done to identify patients at Royal Adelaide, as well as the
second site, Pindara Private Hospital in the Gold Coast. We are grateful to the patient for
consenting to be part of this study. This trial is our initial step
in determining if the Hemopurifier treatment can improve upon the
30-40% response rates to anti-PD-1 therapies such as Opdivo and
Keytruda."
Currently, only approximately 30% of patients who receive
pembrolizumab or nivolumab will have lasting clinical responses to
these agents. EVs produced by tumors have been implicated in the
spread of cancers as well as the resistance to anti-PD-1 therapies.
The Aethlon Hemopurifier has been designed to bind and remove these
EVs from the bloodstream, which may improve therapeutic response
rates to anti-PD-1 antibodies. In preclinical studies, the
Hemopurifier has been shown to reduce the number of exosomes from
the plasma of cancer patient samples.
The primary endpoint of the approximately nine to 18-patient,
safety, feasibility and dose-finding trial is the incidence of
adverse events and clinically significant changes in safety lab
tests of Hemopurifier treated patients with solid tumors with
stable or progressive disease at different treatment intervals,
after a two-month run in period of PD-1 antibody, Keytruda® or
Opdivo® monotherapy. Patients who do not respond to the therapy
will be eligible to enter the Hemopurifier period of the study
where sequential cohorts will receive 1, 2 or 3 Hemopurifier
treatments during a one-week period. In addition to monitoring
safety, the study is designed to examine the number of Hemopurifier
treatments needed to decrease the concentration of EVs and if these
changes in EV concentrations improve the body's own natural ability
to attack tumor cells. These exploratory central laboratory
analyses are expected to inform the design of a subsequent efficacy
and safety, Premarket Approval (PMA), study required by regulatory
agencies.
About Aethlon and the Hemopurifier®
Aethlon Medical is
a medical therapeutic company focused on developing the
Hemopurifier, a clinical stage immunotherapeutic device which is
designed to combat cancer and life-threatening viral infections and
for use in organ transplantation. In human studies, the
Hemopurifier has demonstrated the removal of life-threatening
viruses and in pre-clinical studies, the Hemopurifier has
demonstrated the removal of harmful exosomes from biological
fluids, utilizing its proprietary lectin-based technology. This
action has potential applications in cancer, where exosomes may
promote immune suppression and metastasis, and in life-threatening
infectious diseases. The Hemopurifier is a U.S. Food and Drug
Administration (FDA) designated Breakthrough Device indicated for
the treatment of individuals with advanced or metastatic cancer who
are either unresponsive to or intolerant of standard of care
therapy, and with cancer types in which exosomes have been shown to
participate in the development or severity of the disease. The
Hemopurifier also holds an FDA Breakthrough Device designation and
an open Investigational Device Exemption (IDE) application related
to the treatment of life-threatening viruses that are not addressed
with approved therapies.
Additional information can be found at
www.AethlonMedical.com.
Forward Looking Statements
This press release
contains forward-looking statements within the meaning of Section
27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934 that involve risks and uncertainties.
Statements containing words such as "may," "believe," "anticipate,"
"expect," "intend," "plan," "project," "will," "projections,"
"estimate," "potentially" or similar expressions constitute
forward-looking statements. Such forward-looking statements are
subject to significant risks and uncertainties and actual results
may differ materially from the results anticipated in the
forward-looking statements. These forward-looking statements are
based upon Aethlon's current expectations and involve assumptions
that may never materialize or may prove to be incorrect. Factors
that may contribute to such differences include, without
limitation, the Company's ability to raise additional
capital on terms favorable to the Company, or at
all; the Company's ability to successfully complete
development of the Hemopurifier; the Company's ability to
successfully demonstrate the utility of the Hemopurifier in
patients with solid tumors in our oncology clinical trials; the
Company's ability to achieve and realize the anticipated benefits
from potential milestones; the Company's ability to obtain approval
from the Ethics Committee of its third location in Australia, including on the timeline expected
by the Company; the Company's ability to enroll additional patients
in its oncology clinical trials in Australia and India, including on the timeline expected by
the Company; whether or not patients that are enrolled in the
Company's clinical trials will respond to PD-1 antibody
monotherapy; the number of patients that are enrolled in the
Company's clinical trials that will ultimately be treated with the
Company's Hemopurifier; the Company's ability to manage and
successfully complete its clinical trials; the Company's ability to
successfully manufacture the Hemopurifier in sufficient quantities
for its clinical trials; and other potential risks. The foregoing
list of risks and uncertainties is illustrative but is not
exhaustive. Additional factors that could cause results to differ
materially from those anticipated in forward-looking statements can
be found under the caption "Risk Factors" in the Company's Annual
Report on Form 10-K for the year ended March
31, 2023, and in the Company's other filings with the
Securities and Exchange Commission, including its quarterly Reports
on Form 10-Q. All forward-looking statements contained in this
press release speak only as of the date on which they were made.
Except as may be required by law, the Company does not intend, nor
does it undertake any duty, to update this information to reflect
future events or circumstances.
Company Contact:
Jim Frakes
Chief Executive Officer and Chief Financial Officer
Aethlon Medical, Inc.
Jfrakes@aethlonmedical.com
Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
susan@sanoonan.com
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SOURCE Aethlon Medical, Inc.